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IRCT201110057712N2 IRCT 2011-10-22 Tabriz University of Medical Sciences and Health Services Comparison of hydroxychloroquine with methotrexate in the treatment of patients with localized scleroderma Comparison of hydroxychloroquine with methotrexate in the treatment of patients with localized scleroderma 2011-03-01 anticipated 30 Complete https://irct.ir/trial/8169 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A localized scleroderma. Intervention 1: Group A: oral methotrexate 15 mg Fridays and oral folic acid daily except Fridays for 12 weeks. Intervention 2: Group B: oral hydroxychloroquine 200 mg twice a day, for 12 weeks.
public Maryam Nasimi
Sina Hospital-Azadi Avenue- Tabriz
Tabriz Iran (Islamic Republic of) +98 41 1337 5759 nasimi.maryam@yahoo.com Tabriz University of Medical Sciences and Health Services scientific Hamideh Azimi
Sina Hospital-Azadi Avenue-Tabriz
Tabriz Iran (Islamic Republic of) +98 41 1541 2120 azimih@tbzmed.com Tabriz University of Medical Sciences and Health Services Iran (Islamic Republic of) Inclusion criteria: presence of morphea without any signs of systemic involvement, evidence of active and expanding lesions (evidence of the spreading lesions, the appearance of new lesions or clinical signs of inflammation include erythema and warmth over the past 3 months), morphea confirmed with a histological samples from all patients before treatment, any systemic treatment with effect on morphea had to be discontinued for at least 4 weeks and topical treatments for at least 2 weeks prior to the study, Exclusion criteria: Acute or chronic infection, pregnancy or childbearing potential without an acceptable method to prevent, Liver disease or elevated liver enzyme levels more than twice the normal, creatinine level of more than 130 mmol, known pulmonary disease, leukocyte count less than 3500 or platelet count less than 150000, active peptic ulcer or neoplasm, insulin-dependent diabetes mellitus, Use of other anti-folate drugs such as sulfonamides, and allopurinol and Probenesid, Presence of Lupus or Mixed connective tissue disease (MCTD), Contraindication of Ophthalmology to start hydroxychloroquine no limit no limit Both L94.0 localized scleroderma(morpea) Treatment - Drugs Treatment - Drugs Group A: oral methotrexate 15 mg Fridays and oral folic acid daily except Fridays for 12 weeks Group B: oral hydroxychloroquine 200 mg twice a day, for 12 weeks Improvment of clinical lesion. Timepoint: every 4 weeks. Method of measurement: MSS. Improvment of induration. Timepoint: every 4 week. Method of measurement: VAS(visual analoge scale). Improvment of pruritus. Timepoint: every 4 weeks. Method of measurement: VAS(visual analoge scale). Tabriz University of Medical Sciences and Health Services Approved 2011-06-29 Tabriz University of Medical Sciences and Health Services Tabriz University of Medical Sciences, Daneshghah Avenue, Tabriz Tabriz Iran (Islamic Republic of)